investigate wound healing, aesthetics & pt satisfaction post nac reconstruction using a decellularized donor nac graft

Conditions: Post-Mastectomy Breast Deformity (Disorder)

Summary: to evaluate the wound healing response following nipple-areolar complex (nac) reconstruction with a decellularized donor nac graft (dclnac)

primary objective • to evaluate the wound healing response following nipple-areolar complex (nac) reconstruction with a decellularized donor nac graft (dclnac). secondary objectives * to evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using dclnac. * to evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using dclnac. exploratory objectives * to assess operative time and physician preference for either the dclnac or the standard of care (soc) surgical nac reconstruction procedures. * to evaluate nipple sensitivity.

Eligibility criteria:
inclusion criteria: * general criteria: * females age \>18 and \<65 years old. women of childbearing potential must agree to use an acceptable method of contraception for one month prior to dclnac implantation, and until the graft is 100% healed. acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (iud), male or female condom, diaphragm, sponge, and cervical cap. nonchildbearing potential for women is defined as postmenopausal (last natural menses greater than 12 months) or undergone a documented bilateral tubal ligation or hysterectomy. if last natural menses less than 12 months, a serum fsh value confirming post-menopausal status can be employed. * patient agrees to sleep on back until study tissue products are healed * patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed * patient agrees to not undergo nac tattooing until completing study * patient can understand and willing to sign informed consent * patient desires bilateral nipple reconstruction with dclnac * subjects must be capable of providing written informed consent to the study procedures and for use of protected health information \[health insurance portability and accountability act (hipaa), if applicable\] * specific criteria group a: * patient had a bilateral mastectomy with no radiation therapy * patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study group b: * patient had a unilateral mastectomy with no radiation therapy * patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study group c: * patient had a bilateral mastectomy and received radiation unilaterally * patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study group d: - patient had unilateral or bilateral mastopexy (with or without augmentation) or reduction mammaplasty and suffered nipple complications (i.e., necrosis, projection loss) group e: * patient had unilateral or bilateral mastectomy * patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study * patient did not receive radiation to the autologously reconstructed breast * patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss) group f: - implant based reconstruction exclusion criteria: * patient has a history of delayed wound healing * patient has a history of vitamin c deficiency * bmi\ 40 kg/m2 * patient has a history of allergic reaction to any decellularized biologic matrix product * patient is currently smoking or using tobacco or nicotine products (i.e., patch, gum, vaping or nasal spray) or has used such products in the past 6 months * patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening * patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders * patient is pregnant, breastfeeding or planning to become pregnant during the study period * patient has any type of disease or disorder that in the investigator's opinion would make the patient unfit for the study, including active infection anywhere in the body. * acute mastitis in either breast * history of an autoimmune disorder * use of any medications currently or in the past 3 months that would impair wound healing, such as long-term use of systemic steroids (inhaled, limited topical, short-term oral use and intra-articular steroids are acceptable)